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Daily or As-Needed Airway Clearance Treatments for Children and Teens With Cystic Fibrosis

Compares daily versus as-needed hypertonic saline or dornase alfa in young people with cystic fibrosis.

Plain-language title generated from the registry record
Registry title: Rethinking Early Airway Clearence Therapies

Key facts

Where
Ann Arbor, Atlanta, Aurora, Baltimore, Birmingham, Boston, Chapel Hill, Charleston, Charlottesville, Chicago, Cincinnati, Cleveland, Columbus, Dallas, Dayton, Houston, Indianapolis, Iowa City, Kansas City, Los Angeles, Madison, Milwaukee, Minneapolis, Orange, Palo Alto, Philadelphia, Pittsburgh, Portland, Richmond, Rochester, Seattle, Spokane, St Louis, St. Petersburg, and Tucson, United StatesSee the 36 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teens with cystic fibrosis who already take ETI or VTD. It tests daily versus only-when-sick hypertonic saline or dornase alfa.

Age
3 to 16 years
Sex
All genders
Disease stage
Documented cystic fibrosis, clinically stable for 28 days. If able to do spirometry, FEV1 at least 70% predicted.
Earlier treatment
Must have taken elexacaftor/tezacaftor/ivacaftor (ETI) or vanzacaftor/tezacaftor/deutivacaftor (VTD) for at least 90 days and be willing to keep taking it daily during the study.

Main reasons for not taking part

  • Used an investigational drug within 28 days before screening
  • Started a new long-term therapy (for example azithromycin, inhaled tobramycin, inhaled aztreonam) within 28 days
  • Took antibiotics or systemic corticosteroids for breathing symptoms within 28 days
  • Had antibiotic treatment for nontuberculous mycobacteria within 28 days
  • FEV1 % predicted dropped by 10% or more between screening and Visit 1

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 3 and 16 years old?

Source: NCT07696338, who can take part

Where in United States

  • University of Michigan - Michigan MedicineAnn Arbor, United StatesNo longer taking part
  • Children's Healthcare of Atlanta and Emory UniversityAtlanta, United StatesNo longer taking part
  • Children's Hospital ColoradoAurora, United StatesNo longer taking part
  • John Hopkins HospitalBaltimore, United StatesNo longer taking part
  • The Children's Hospital Alabama & University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
  • Boston Children's HospitalBoston, United StatesNo longer taking part
  • University of North Carolina at Chapel HillChapel Hill, United StatesNo longer taking part
  • Medical University of South CarolinaCharleston, United StatesNo longer taking part
  • University of VirginiaCharlottesville, United StatesNo longer taking part
  • Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, United StatesNo longer taking part
  • Cincinnati Children's Hospital Medical CenterCincinnati, United StatesNo longer taking part
  • Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical CenterCleveland, United StatesNo longer taking part
  • Nationwide Children's HospitalColumbus, United StatesNo longer taking part
  • University of Texas Southwestern, Children's HealthDallas, United StatesNo longer taking part
  • Dayton Children's HospitalDayton, United StatesNo longer taking part
  • Baylor College of MedicineHouston, United StatesNo longer taking part
  • Riley Hospital for ChildrenIndianapolis, United StatesNo longer taking part
  • University of IowaIowa City, United StatesNo longer taking part
  • Children's Mercy Kansas CityKansas City, United StatesNo longer taking part
  • Childrens Hospital Los AngelesLos Angeles, United StatesNo longer taking part
  • University of WisconsinMadison, United StatesNo longer taking part
  • Children's WisconsinMilwaukee, United StatesNo longer taking part
  • Children's Hospitals and Clinics of MinnesotaMinneapolis, United StatesNo longer taking part
  • The Minnesota Cystic Fibrosis CenterMinneapolis, United StatesNo longer taking part
  • CHOC Children's HospitalOrange, United StatesNo longer taking part
  • Stanford University Medical CenterPalo Alto, United StatesNo longer taking part
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesNo longer taking part
  • Children's Hospital of Pittsburgh of UPMCPittsburgh, United StatesNo longer taking part
  • Oregon Health Sciences UniversityPortland, United StatesNo longer taking part
  • Virginia Commonwealth UniversityRichmond, United StatesNo longer taking part
  • University of Rochester Medical Center Strong MemorialRochester, United StatesNo longer taking part
  • Seattle Children's HospitalSeattle, United StatesNo longer taking part
  • Providence Medical Group, Cystic Fibrosis Clinic - PediatricsSpokane, United StatesNo longer taking part
  • St. Louis Children's HospitalSt Louis, United StatesNo longer taking part
  • All Children's HospitalSt. Petersburg, United StatesNo longer taking part
  • Tucson Cystic Fibrosis CenterTucson, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Nicole Hamblett
Trial code
NCT07696338
Record updated
10 July 2026
Original description
The REACT trial consists of two parallel, randomized studies; the Hypertonic Saline Study and the Dornase Alfa Study.Read full original descriptionShow less

Rethinking Early Airway Clearence Therapies

The REACT trial consists of two parallel, randomized studies; the Hypertonic Saline Study and the Dornase Alfa Study.

Health outcomes among people with cystic fibrosis (CF) have been steadily improving, most recently with the advent of highly effective modulator therapy (HEMT). While therapies like hypertonic saline (HS) and dornase alfa (DA) improved outcomes in the past, they are often burdensome. Now that almost 90% of the North American CF population is being treated with elexacaftor/tezacaftor/ivacaftor (ETI) or vanzacaftor/tezacaftor/deutivacaftor (VTD), this trial will evaluate whether these newer treatments make daily HS or DA unnecessary. The trial begins with a 6-week run-in period where participants continue ETI or VTD but stop using HS and DA. Eligible participants are then assigned to either the HS Study or the DA Study for one year. Within those groups, they are randomized to either daily use of HS or DA or as needed use only during respiratory illnesses. The study aims to find out if lung health is similar between children and teens taking HEMT who use HS or DA treatments daily and those who use HS or DA treatments only when they are sick.

Inclusion: All genders ≥ 3 and ≤ 16 years of age; Documentation of a CF diagnosis; If capable of completing spirometry, forced expiratory volume in 1 second (FEV1) ≥ 70 % predicted at the Screening Visit; Clinically stable with no significant changes in health status within the 28 days prior to and including Screening Visit; MBW test meets acceptability criteria at the Screening Visit; On elexacaftor/tezacaftor/ivacaftor (ETI) or vanzacaftor/tezacaftor/deutivacaftor (VTD) for at least 90 days prior to and including Screening (modified dose permissible) and willing to continue daily use of either ETI or VTD for the duration of the study; Clinically stable with no significant changes in health status for 28 days prior to Visit 1; MBW test meets acceptability at Visit 1; Completed at least 60% of weekly electronic treatment diaries; Take at least one dose of ETI or VTD per weekly electronic treatment diaries.

Exclusion: No use of an investigational drug within 28 days prior to and including Screening Visit; No initiation of new chronic therapy (e.g., azithromycin, inhaled tobramycin, inhaled aztreonam) within 28 days prior to and including Screening Visit; No acute use of antibiotics (oral, inhaled, or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 28 days prior to and including Screening Visit; No antibiotic treatment for nontuberculous mycobacteria (NTM) within 28 days prior to and including the Screening Visit; No acute use of antibiotics (oral, inhaled or IV), systemic corticosteroids, hypertonic saline, or dornase alfa for respiratory tract symptoms within 28 days prior to and including Visit 1; No absolute decrease in FEV1 % predicted of ≥10% from the Screening Visit to Visit 1 (in participants who performed acceptable and reproducible spirometry at both visits).

ClinicalTrials.gov NCT07696338